Status:
RECRUITING
Pre-operative Polyethylene Glycol 3350 for Minimally Invasive Urogynecologic Surgery
Lead Sponsor:
University Hospitals Cleveland Medical Center
Conditions:
Constipation
Surgical Procedure, Unspecified
Eligibility:
FEMALE
18-89 years
Phase:
PHASE4
Brief Summary
The goal of this clinical trial is to test the use of a laxative before surgery in women having surgery to fix pelvic prolapse that do not have constipation. The main question it aims to answer is: D...
Detailed Description
The purpose of this study is to evaluate if there is a difference in bother related to constipation between a pre-operative versus post-operative start of a bowel regimen for patients undergoing surge...
Eligibility Criteria
Inclusion
- Patients assigned female sex at birth undergoing an apical prolapse procedure including: sacrocolpopexy, sacrospinous ligament suspension, uterosacral ligament suspension, or colpocleisis. Planned urogynecologic procedure may include hysterectomy, adnexectomy, colporrhaphy, perineorrhaphy, or treatment of stress urinary incontinence.
- Planning to undergo primary procedure as above via minimally invasive route: vaginal or laparoscopic (including robotic-assisted). Including those that have an unplanned conversion intraoperatively of minimally invasive route to open laparotomy.
Exclusion
- Diagnosis of irritable bowel syndrome, inflammatory bowel disease, slow transit constipation, obstructed defecation, or symptomatic constipation at time of study screening and recruitment. (Slow transit constipation and obstructed defecation defined as per American Gastroenterological Association 2013 constipation statement. Symptomatic constipation defined as any of the following: Bristol Stool Scale score of 1 or 2, PAC-SYM score greater than 1.0, self-reported 2 or less bowel movements per week.)
- Current use of pharmacologic laxative agent ≥1x/week (prescription or OTC) for the treatment of constipation symptoms
- Allergy or intolerance to polyethylene glycol 3350
- Planning to undergo surgery via laparotomy
- Scheduled for any concurrent non-urogynecologic procedure, ex abdominoplasty
- History of large bowel resection, surgical treatment of constipation, or anal sphincter surgery
- History of sacral neuromodulation
- Current or prior radiation therapy to the abdomen or pelvis
- Current or prior diagnosis of malignancy
- Unable to provide informed consent
Key Trial Info
Start Date :
June 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT06159777
Start Date
June 5 2024
End Date
April 30 2026
Last Update
January 7 2026
Active Locations (1)
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1
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106